How to Comply with DQSA Requirements for Serialization & Traceability
Posted on March 4, 2015
What is the Drug Quality Security Act?
The Drug Quality Security Act (DQSA) is an important US law that aims to create and establish an electronic traceability system for pharmaceutical drugs. As of January 2015, the new serialization system began.
What is a DQSA-Compliant Label?
With this new policy, prescription drugs will now be tracked by the FDA. They’ll be tracked down to the individual dose by a serial number that will be printed right on the label of your prescription drugs. The serial number will be stored in an FDA database. If you’re wondering what the label needs to look like, it’ll be something like this:
But what truly are the benefits of traceability? Well, first and foremost, it’s important to comply with federal regulations. But, besides that, you can actually enhance the reputation of your brand, and draw attention to your safe practices.
Along with those benefits, traceability also:
- Promises consumer safety
- Protects your product from fraud and counterfeiting
- Improves your product’s efficiency
- As of January 2015, the lot-level traceability system begins.
- As of late November of 2017, manufacturers will be required to serialize pharmaceutical products.
- By November 27, 2023, the law will require the complete transition to an electronic, interoperable traceability system at the package level. (source)
Why do we need the DQSA?
The DQSA keeps consumers safer. You may recall the incident in 2013 in which a strain of fungal meningitis was spread via a small compounding pharmacy in Massachusetts. The DQSA was strengthened as a direct result of that event.
The new DQSA serialization requirement will allow the FDA to view a product’s history, much like a browsing history on an Internet application. By allowing the FDA to view history, it will enable suspect products and illegitimate products to be sniffed out and taken care of before a consumer gets to them.
Who Does the DQSA affect?
The DQSA will affect:
- Wholesale distributors
- Third-party logistics
All of these groups will have different rules to follow when it comes to complying with the Drug Quality and Security Act.
- Manufacturer: When the DQSA defines a manufacturer, it means a company that:
“(A) Holds an application approved under section 505 or such a license issued under section 351 of the Public Health Service Act for such a [pharmaceutical] product, or if such a product is not the subject of an approved application or license, the person who manufactured the product.
(B) a co-licensed partner of that company
(C) an affiliate of that company that receives the product directly from the producer or a co-licensed partner (Section 581)
- Re-Packager: A re-packager is considered “a person who owns or operates an establishment that repacks and re-labels a product or package for further resale or distribution without a further transaction.” (Section 581)
- Third-Party Logistics: Third-Party Logistics is the activity of outsourcing activities related to Logistics and Distribution. (Logistics List)
- Wholesale Distributor: A Certified Wholesale Distributor is a company who handles wholesale shipments for the manufacturer of a product (or in some cases is the product manufacturer). They have a warehouse, distribution center, and ship products directly to the retailer. (World Wide Brands)
How Can Your Pharma Labels Communicate Safety?
Your product labels can do more than just comply with the DQSA serialization requirement. They can show your commitment to safety by using photos, graphics, and color codes to assists patients and caregivers. Printing a color label with a photo of a pill that matches the correct dosage, printing a label with a photograph of a patient, and printing labels with color-coded areas will all increase patient safety. We recommend that you investigate the benefits of using a QL-120X color label printer to print your pharmaceutical labels.
If You Want to Know More…
- Drug Quality & Security Act: Meeting Supply Chain Responsibilities https://www.fdli.org/docs/dqsa-2014/e-jungman_fdli-dqsa-2-20-14.pdf?sfvrsn=0
- Pharmaceuticals, Traceability, E-Pedigree, and Obama’s ‘Other’ Healthcare Law http://supplychaindharma.com/pharmaceuticals-traceability-e-pedigree-obama-healthcare-law
- Drug Supply Chain Security Act (DSCSA), Title II of the Drug Quality and Security Act of 2013 http://www.fda.gov/drugs/drugsafety/drugintegrityandsupplychainsecurity/drugsupplychainsecurityact/